Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of PF-4217903 in Patients With Advanced Cancer
The study was prematurely discontinued due to a strategic development decision by Pfizer on
10FEB2012. The decision to terminate was not based on any safety concerns.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities.
Baseline up to 21 days after the start of each increased treatment dose
Pfizer CT.gov Call Center
United States: Food and Drug Administration
|Pfizer Investigational Site||Detroit, Michigan 48201|
|Pfizer Investigational Site||Springfield, Illinois 62701-1014|
|Pfizer Investigational Site||Aurora, Colorado 80012|
|Pfizer Investigational Site||North Adams, Massachusetts 01247|